NCT00450593

Brief Summary

RATIONALE: Identifying gene mutations and other risk factors in patients with melanoma and in families with a history of hereditary melanoma may help doctors identify persons at risk for melanoma and other types of cancer. It may also help the study of cancer in the future. PURPOSE: This clinical trial is studying gene mutations in patients with melanoma and in families with a history of hereditary melanoma.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1989

Completed
18.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

August 12, 2013

Status Verified

April 1, 2008

Enrollment Period

31.9 years

First QC Date

March 20, 2007

Last Update Submit

August 9, 2013

Conditions

Keywords

melanomahereditary multiple melanomarecurrent melanomastage 0 melanomastage IV melanomastage IA melanomastage IB melanomastage IIA melanomastage IIB melanomastage IIC melanomastage IIIA melanomastage IIIB melanomastage IIIC melanoma

Outcome Measures

Primary Outcomes (4)

  • Predictive significance of melanoma susceptibility gene (MSG) mutations in the CDKN2A gene

  • Susceptibility to other types of cancer as a feature of MSG mutations

  • Risk of other types of cancers in mutation carriers

  • Environmental exposures, in particular sun exposure, that modify risk of melanoma in MSG mutation carriers

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Prior multiple primary melanomas * Histological samples available * Family history of melanoma, with melanoma in two first-degree relatives (e.g., cases of melanoma in both a mother and son or in two brothers but not in two cousins) * Family history of melanoma, where three or more individuals (of any relationship) have had melanoma PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Melanoma, Cutaneous MalignantMelanoma

Interventions

Gene Expression ProfilingMicroarray AnalysisGenetic Testing

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Julia Newton Bishop, MD

    Leeds Cancer Centre at St. James's University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

January 1, 1989

Primary Completion

December 1, 2020

Last Updated

August 12, 2013

Record last verified: 2008-04

Locations